Zephyr Sleep Technologies : FDA 510 (k) Clearance for MATRx™

March 28, 2012 - Zephyr Sleep Technologies Inc. (Zephyr) is pleased to announce that they have been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin selling the MATRx medical device system.

The MATRx system will be used in sleep laboratories to identify patients that will be successful with oral appliance therapy while establishing the protrusive position of the lower mandible for effective therapy. “The MATRx system changes the way oral appliance therapy is prescribed, bringing the knowledge and expertise of both Sleep Physicians and Dentists into the therapy decision much earlier. This new technology will certainly change how things are done” says Paul Cataford, Zephyr’s President & CEO.

A MATRx study is performed in a sleep laboratory by a sleep technician in conjunction with a polysomnographic study (“PSG test”). Using this new technology Sleep Physicians will, for the first time, be able to reliably predict the effectiveness of oral appliance therapy as a treatment for obstructive sleep apnea patients. This clears the way for Sleep Physicians to confidently prescribe oral appliance therapy in advance of patients being fitted with an oral appliance. MATRx also provides Sleep Dentists with an effective target protrusive position for the lower mandible. This enables dentists to fit oral appliances with confidence in therapeutic outcome while eliminating the need for an iterative titration process that previously could take weeks.

“Understanding a patient’s airway response to mandibular protrusion is a critical component of confidently prescribing and administering oral appliance therapy. The MATRx study offers many features that are comparable to and commensurate with the traditional continuous positive airway pressure study (“CPAP study”). In fact, the two studies can now work hand-in-hand to optimize sleep apnea management.” says Zephyr’s Chief Medical Officer, Dr. John Remmers.

In Dec 2010, Zephyr signed an exclusive worldwide distribution agreement with SomnoMed Limited to market and sell this device under the name SomnoMed MATRx... [PDF] Zephyr Sleep Technologies' Press Release -

SomnoMed : New Product Line to Treat Sleep Bruxism

19th January 2010 - SomnoMed, the world’s leading dental sleep appliance company, announced the launch of SomnoMed Brux (SomBrux™), an innovative new range of products treating sleep bruxism. Sleep Bruxism (“SB”) is a common sleep-related movement disorder that is characterised by clenching or grinding of the jaws or teeth.
Medical studies indicate a prevalence of approximately 8% in the adult population of western societies and an equal occurrence in men and women. The condition is currently treated with a wide range of products, mostly individually made by dental technicians. Based on company research, the global market is currently in excess of 2 million units per year, representing a wholesale value of around US$ 200 to $300 million, with an annual growth tendency of 8 to 12%.
The new SomnoMed Brux product line will be introduced in Australia in February 2010, followed during the year by launches in all major global markets where SomnoMed is represented. SomBrux™, like the leading SomnoDent® device treating sleep apnea, is custom made and offered in various designs. It is expected that one of its unique selling points is the use of SomnoMed’s SMH BFlex material, which offers unrivalled patient comfort and durability... [PDF] SomnoMed's Press Release -